Teva Pharmaceuticals has asked the Food and Drug Administration (FDA) to remove more than 200 patent listings from the FDA’s Orange Book after being challenged by the Federal Trade Commission (FTC). The request follows warning letters sent by the FTC in May 2025 to Teva and other pharmaceutical companies, leading to most of the disputed listings being withdrawn.
The FTC's actions are part of a wider effort to promote competition in the pharmaceutical industry and reduce drug prices. These efforts align with President Trump’s Executive Order on Lowering Drug Prices. Improperly listed patents can block generic alternatives from entering the market, which can keep prices high and limit patient access to less expensive drugs. The removal of these listings is expected to open up competition for generic versions of more than 30 drugs used to treat asthma, diabetes, chronic obstructive pulmonary disease (COPD), and for epinephrine autoinjectors.
“President Trump has promised Americans access to prescription drugs at lower costs. The FTC is fighting to help deliver on that promise,” said FTC Chairman Andrew N. Ferguson. “When improper patent listings limit competition from generic alternatives, it hurts Americans’ bank accounts and more importantly, it can endanger their health. The Trump-Vance FTC is working hard to ensure that Americans have access to the affordable prescription drugs they need.”
The FTC's challenge came after a decision from the U.S. Court of Appeals for the Federal Circuit found that Teva’s patents were improperly listed, a position consistent with an amicus brief submitted by the FTC. The agency stated it will continue monitoring the pharmaceutical sector for similar issues and other anticompetitive practices.
The Federal Trade Commission states its mission is to promote competition and protect consumers through education and enforcement actions. It advises consumers that it will never demand money or make threats regarding transfers or prizes. Information about consumer benefits from competition, filing antitrust complaints, proposed merger comments, as well as news updates and resources can be found through official FTC channels online.
